Acumen’s ACU193, an Anti-Amyloid Beta Oligomer Antibody, Granted FDA Fast Track Designation for Alzheimer's Disease
October 24 2022 - 8:00AM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) today announced that
ACU193, the first clinical-stage monoclonal antibody that
selectively targets toxic soluble amyloid beta oligomers (AβOs),
has been granted Fast Track designation for the treatment of early
Alzheimer’s disease by the U.S. Food and Drug Administration (FDA).
ACU193 is currently being studied in the Phase 1 INTERCEPT-AD trial
designed to assess safety and proof of mechanism of ACU193.
ACU193 is a humanized monoclonal antibody
discovered and developed based on its selectivity for soluble AβOs,
which scientific evidence shows are the most toxic and pathogenic
form of Aβ, relative to Aβ monomers and amyloid plaques. Some types
of toxic soluble AβOs have been found to interact within synapses
which leads to altered neuronal function, and can initiate and
perpetuate the process of neurodegeneration, ultimately leading to
cell death. ACU193 binds AβOs that bind to synapses, and due to its
unique binding profile, ACU193 has potential to provide therapeutic
benefit with low risk of amyloid-related imaging abnormalities
(ARIA), because ACU193 blocks the toxic effects of AβOs without
directly targeting amyloid plaques.
“We are encouraged to receive Fast Track
designation for ACU193, reflecting its potential clinical utility
to treat Alzheimer’s disease,” said Daniel O’Connell, President and
Chief Executive Officer of Acumen. “We look forward to
collaborating with the FDA to advance the development of ACU193.
Treating Alzheimer’s disease ultimately requires therapies that
target different components of the disease pathway, and we are
developing ACU193 with the goal of providing patients with more
treatment options.”
The FDA Fast Track program is designed to
facilitate the development and expedite the review of new drugs
intended to treat serious or life-threatening conditions with the
potential to fill an unmet medical need. The Fast Track designation
allows Acumen to have more frequent engagement with the FDA to
discuss development plans and clinical study design for ACU193 to
ensure collection of appropriate data to support evaluation for
approval.
About ACU193
ACU193 is a humanized monoclonal antibody (mAb) discovered and
developed based on its selectivity for soluble AβOs, which Acumen
believes are the most toxic and pathogenic form of Aβ, relative to
Aβ monomers and amyloid plaques. Soluble AβOs have been observed to
be potent neurotoxins that bind to neurons, inhibit synaptic
function and induce neurodegeneration. By selectively targeting
toxic soluble AβOs, ACU193 aims to directly address what a growing
body of evidence indicates is a primary underlying cause of the
neurodegenerative process in AD.
About INTERCEPT-AD
Approximately 62 individuals with early AD (mild cognitive
impairment or mild dementia due to AD) are expected to be
randomized into this double-blind, placebo-controlled,
first-in-human study of ACU193. INTERCEPT-AD is designed to
establish safety and proof of mechanism. It consists of
single-ascending-dose (SAD) and multiple-ascending-dose (MAD)
cohorts and is designed to evaluate the safety, tolerability,
pharmacokinetics (PK), and target engagement of intravenous doses
of ACU193. The study is enrolling at multiple investigative sites
located in the United States. More information can be found on
www.clinicaltrials.gov, NCT identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA,
with clinical operations based in Carmel, IN, is a clinical stage
biopharmaceutical company developing a novel disease-modifying
approach to treat Alzheimer’s disease. Acumen’s scientific founders
pioneered research on AβOs, which a growing body of evidence
indicates are primary triggers of Alzheimer’s disease pathology.
Acumen is currently focused on advancing its investigational
product candidate, ACU193, a humanized monoclonal antibody that
selectively targets toxic soluble AβOs in INTERCEPT-AD, a Phase 1
clinical trial involving early Alzheimer’s disease patients. For
more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release contains forward‐looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Any statement describing Acumen’s goals,
expectations, financial or other projections, intentions or beliefs
is a forward‐looking statement and should be considered an at‐risk
statement. Words such as “believes,” “expects,” “anticipates,”
“could,” “would,” “seeks,” “aims,” “plans,” “potential,” “will” and
similar expressions are intended to identify forward‐looking
statements, although not all forward‐looking statements contain
these identifying words. Forward‐looking statements include
statements concerning Acumen’s business and the therapeutic
potential of Acumen’s product candidate, ACU193, including its
potential for improved safety and efficacy as compared to other
monoclonal antibodies in development, and expectations with respect
to the role of toxic soluble AβOs in the potential treatment of
Alzheimer’s disease. These statements are based upon the current
beliefs and expectations of Acumen management, and are subject to
certain factors, risks and uncertainties, particularly those
inherent in the process of discovering, developing and
commercializing safe and effective human therapeutics. Such risks
may be amplified by the impacts of the COVID‐19 pandemic. These and
other risks concerning Acumen’s programs are described in
additional detail in Acumen’s filings with the Securities and
Exchange Commission (“SEC”), including in Acumen’s Annual Report on
Form 10‐K for the year ended December 31, 2021, filed with the SEC
on March 28, 2022, which is available on the SEC’s website at
www.sec.gov, and its other documents subsequently filed with or
furnished to the SEC. Copies of these and other documents are
available from Acumen. Additional information will be made
available in other filings that Acumen makes from time to time with
the SEC. These forward‐looking statements speak only as of the date
hereof, and Acumen expressly disclaims any obligation to update or
revise any forward‐looking statement, except as otherwise required
by law, whether, as a result of new information, future events or
otherwise.
Contacts:
Media:AcumenPR@westwicke.com
Investors:investors@acumenpharm.com
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